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Assocation Between In-person Instruction and COVID-19 Risk (Campus&Corona)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04529421
Recruitment Status : Not yet recruiting
First Posted : August 27, 2020
Last Update Posted : September 1, 2020
Sponsor:
Collaborator:
Norwegian Institute of Public Health
Information provided by (Responsible Party):
Atle Fretheim, Oslo Metropolitan University

Brief Summary:
Whether university teaching on campus with infection control measures in place is associated with higher risk of COVID-19 than online instruction, is unknown. The investigators will assess this by conducting repeated surveys among students at universities and university colleges in Norway, where some instruction is given in-person, and some is provided online (hybrid model). The investigators will ask about the students' COVID-19 status, and how much in-person and online instruction the students are getting. The investigators will estimate the association between in-person instruction and COVID-19-risk using multivariate regression, controlling for likely confounders. The investigators will also assess whether type of instruction is associated with how satisfied the students are with the instruction the students are offered, their quality of life, and learning outcomes.

Condition or disease Intervention/treatment
Infection Infection Control Behavioral: Online instruction Behavioral: In-person instruction

Detailed Description:

The investigators are inviting all universities and university colleges in Norway to take part. All students at institutions that agree to participate will receive an SMS (alternatively an e-mail) inviting them to take part in the study. The invitation includes a link that directs participants to a web-based informed consent-form and questionnaire. The investigators will use the University of Oslo's solutions for online consent form, web-based survey (Nettskjema), and secure storage of research data (TSD).

The investigators will ask the participants if the participants have been tested for COVID-19, the results of such a test, how much in-person instruction the students have been offered, and how much online instruction the students have been offered. The investigators will also inquire about other risk factors for COVID-19 and background variables that may be included as potential adjustment factors (confounders) in the analyses (see Attachment 1 - Questionnaire).

The investigators will survey the students every two weeks by new invitations by SMS or e-mail. The study period will last as long as the universities maintain their arrangement with in-person instruction for only select groups of students. The investigators plan for a study period that lasts for the remainder of 2020. The investigators will ask for the participants consent to link the survey results to information on study programme, basis for admission, study status, academic results, sex and age from the Common Student System.

The investigators will run multivariate regressions to test whether there is an association between in-person instruction and the outcomes.

In-person instruction is a continuous variable, defined as

(Number of days offered in-person instruction) / (Number of days offered in-person instruction + Number of days offered online instruction)

The investigators will control for potentially confounding variables, including year of study program, field of study, age, and gender. The investigators plan for separate analyses for each participating university/university college, and a pooled analysis across institutions.

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Study Type : Observational
Estimated Enrollment : 70000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Relationship Between In-person Instruction and COVID-19 Incidence Among University Students: A Prospective Cohort Study
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Students, Higher Education Institution 1
All students at Higher Education Institution 1 who agree to take part in study.
Behavioral: Online instruction
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.

Behavioral: In-person instruction
For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).

Students, Higher Education Institution 2
All students at Higher Education Institution 2 who agree to take part in study.
Behavioral: Online instruction
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.

Behavioral: In-person instruction
For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).

Students, Higher Education Institution 3
All students at Higher Education Institution 3 who agree to take part in study.
Behavioral: Online instruction
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.

Behavioral: In-person instruction
For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).

Students, Higher Education Institution 4
All students at Higher Education Institution 4 who agree to take part in study.
Behavioral: Online instruction
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.

Behavioral: In-person instruction
For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).

Students, Higher Education Institution 5
All students at Higher Education Institution 5 who agree to take part in study.
Behavioral: Online instruction
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.

Students, Higher Education Institution 6
All students at Higher Education Institution 6 who agree to take part in study.
Behavioral: Online instruction
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.

Behavioral: In-person instruction
For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).

Students, Higher Education Institution 7
All students at Higher Education Institution 7 who agree to take part in study.
Behavioral: Online instruction
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.

Behavioral: In-person instruction
For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).

Students, Higher Education Institution 8
All students at Higher Education Institution 8 who agree to take part in study.
Behavioral: Online instruction
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.

Behavioral: In-person instruction
For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).

Students, Higher Education Institution 9
All students at Higher Education Institution 9 who agree to take part in study.
Behavioral: Online instruction
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.

Behavioral: In-person instruction
For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).

Students, Higher Education Institution 10
All students at Higher Education Institution 10 who agree to take part in study.
Behavioral: Online instruction
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.

Behavioral: In-person instruction
For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).

Students, Higher Education Institution 11
All students at Higher Education Institution 11 who agree to take part in study.
Students, Higher Education Institution 12
All students at Higher Education Institution 12 who agree to take part in study.



Primary Outcome Measures :
  1. COVID-19 incidence [ Time Frame: Through study completion, i.e. 4 months. ]
    Self-reported positive test results


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: Through study completion, i.e. 4 months. ]
    Self-reported ("Overall, how satisfied are you with life right now?")

  2. Satisfaction with teaching [ Time Frame: Through study completion, i.e. 4 months. ]
    Self-reported ("Overall, how satisfied have you been with the teaching you have received in the past 14 days?")

  3. COVID-19 testing incidence [ Time Frame: Through study completion, i.e. 4 months. ]
    Self-reported

  4. Learning outcome [ Time Frame: End of term, December 2020. ]
    Exam results from Common Student System



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All university of university college students who agree to participate.
Criteria

Inclusion Criteria:

  • Student enrolled at university or university college
  • Agrees to participate (signed consent form)

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04529421


Contacts
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Contact: Atle Fretheim, PhD +4791649828 atle.fretheim@fhi.no
Contact: Arnfinn Helleve, PhD +4793046659 arnfinn.helleve@fhi.no

Locations
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Norway
Oslo Metropolitan University
Oslo, Norway, 0130
Contact: Atle Fretheim, PhD    91649828    atle.fretheim@fhi.no   
Contact: Gro Jamtvedt, PhD       groj@oslomet.no   
Sponsors and Collaborators
Oslo Metropolitan University
Norwegian Institute of Public Health
Investigators
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Principal Investigator: Atle Fretheim, PhD Oslo Metropolitan University
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Responsible Party: Atle Fretheim, Adjunct Professor, Oslo Metropolitan University
ClinicalTrials.gov Identifier: NCT04529421    
Other Study ID Numbers: 172155
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We plan to make the full data set publicly available, after ensuring the re-identification of individuals is not possible.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: From spring 2021 and for at least 5 years.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Atle Fretheim, Oslo Metropolitan University:
COVID-19
Social distancing
Digital instruction
In-person instruction
Campus
University
College
Higher education institutions
Additional relevant MeSH terms:
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Infection
Communicable Diseases